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Analytical techniques for peptide-based drug development: Characterization, stability and quality control
Research Scientist III, Analytical R&D, Amneal Pharmaceuticals, NJ, USA MS in pharmaceutical manufacturing engineering.
Research Article
International Journal of Science and Research Archive, 2024, 12(01), 3140-3159.
Article DOI: 10.30574/ijsra.2024.12.1.1108
Publication history:
Received on 08 May 2024; revised on 17 June 2024; accepted on 20 June 2024
Abstract:
The application of peptide-based drugs has attracted considerable interest because peptides demonstrate therapeutic abilities for treating multiple diseases starting, from cancer to metabolic problems and infectious diseases. However, the inherent structural complexity and susceptibility to degradation present significant challenges in drug formulation, stability, and regulatory approval. Strong analytical methods must exist to analyze peptide therapeutics because they are essential in determination, stability evaluation, and quality monitoring. The study examines major analytical techniques used during peptide-based drug development by studying spectroscopic, chromatographic, and mass spectrometric methods for characterizing substances. High-performance liquid chromatography (HPLC) together with ultra-performance liquid chromatography (UPLC) operate as the established techniques for purity evaluation and impurity detection alongside mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy systems which deliver complete structural information about compounds. The analysis of stability plays a critical role because peptides tend to degrade through enzymatic activity and undergo oxidation and aggregation processes. The stability evaluation of peptides under different conditions utilizes three methods: forced degradation studies, circular dichroism, and differential scanning calorimetry (DSC). Quality control measures help pharmaceutical manufacturers maintain regulatory compliance following the FDA, EMA, and ICH. This paper creates a thorough examination of these analytical solutions while exploring their benefits together with their weaknesses. Learning about these techniques is crucial for enhancing peptide formulation, extending drug shelf stability, and obtaining regulatory specifications. Modern developments in computer modeling, automatic approaches, and hybrid analysis techniques will boost the accuracy and operational speed of peptide medicines development.
Keywords:
Peptide-Based Drugs; Analytical Techniques; Characterization; Stability Analysis; Quality Control; Chromatography; Mass Spectrometry; Regulatory Compliance
Full text article in PDF:
This paper has received BEST PAPER AWARD of Volume 12 - Issue 1 (May - June 2024).
Copyright information:
Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
